HealthyOGSNCT07482644
Efficacy and Safety of an Essential Oil-Based Product System for Immune Support
A study testing Essential Oil Blend (Botanical Combination Product) in people with Healthy, run by dōTERRA International at 1 site in United States.
Trial summary
This randomized, double-blind, placebo-controlled clinical trial will evaluate the safety and efficacy of an essential oil-based product system for immune support in healthy adolescents and adults aged 18-45 years. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Essential Oil Blend (Botanical Combination Product)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2026to 17 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female participants aged 18 to 45 years
- Able to read, write, and understand English
- Willing and able to attend study visits at the study site
- Willing to comply with study procedures, including daily use of assigned study product for 30 days
- Willing to refrain from use of essential oils (topical, aromatic, or internal) outside of the study during the study period
- If previously using essential oils regularly (defined as more than 3 times per week for 2 or more weeks in the past month), must complete a washout period of at least 1 month prior to enrollment
Who cannot join
- Known asthma, chronic obstructive pulmonary disease (COPD), chronic lung disease, heart disease, or other medical condition that would make inhalation of essential oils unsafe, as determined by the investigator
- Known allergy or hypersensitivity to essential oils or components of the placebo preparation
- Current use of tobacco products, including smoking, vaping, or chewing tobacco
- Use of recreational drugs
- Pregnant or breastfeeding, or pregnancy within the past 3 months
- Current regular use of essential oils (defined as more than 3 times per week for 2 or more weeks within the past month) without completion of a 1-month washout period
- Initiation of new botanical supplements during the study period
- Any medical, psychiatric, or social condition that, in the opinion of the investigator, would interfere with safe participation or study compliance
Trial locations and contacts
1 site in 1 country.
About this study
This randomized, double-blind, placebo-controlled clinical trial will evaluate the safety and efficacy of an essential oil-based product system for immune support in healthy adolescents and adults aged 18-45 years. Participants will be randomized to receive aromatic, topical, internal, or combined use of the investigational product or matching placebo for 30 days.
The aromatic intervention consists of overnight diffusion, the topical intervention consists of diluted application to specified areas prior to bedtime, and the internal intervention consists of oral capsule administration twice daily. Study visits will occur at baseline and at the end of the 30-day intervention period.
Read more
Primary outcomes include changes in immune-related biomarkers, including complete blood count, comprehensive metabolic panel, salivary immunoglobulin A (IgA), and inflammatory cytokines (IL-6, TNF-α, IL-10). Epigenetic markers will also be evaluated. Secondary outcomes include validated subjective assessments of immune status and overall well-being, as well as evaluation of safety and tolerability.
The study includes an adaptive design with interim analysis to assess enrollment and study continuation parameters.
Read the detailed description
This study is a randomized, double-blind, placebo-controlled, parallel-group clinical trial designed to evaluate the safety and efficacy of a multi-modal essential oil-based product system in healthy adolescents and adults aged 18-45 years. Approximately 20 participants per arm will be enrolled and randomized, with the option for sample size expansion following a planned interim analysis.
Participants will be randomized to receive either the investigational product or matching placebo administered through one of four intervention approaches: aromatic use, topical use, internal use, or combined use of all three modalities. The intervention period will be 30 days.
The aromatic intervention consists of diffusion of the assigned product overnight (approximately 8 hours) using a standardized protocol. The topical intervention consists of application of a diluted preparation to specified skin areas prior to bedtime. The internal intervention consists of oral capsule administration twice daily with meals. Participants assigned to the combined group will use all three modalities concurrently. Placebo preparations will be matched for appearance and administration method.
Study assessments will occur at baseline and at the end of the 30-day intervention period. Biological samples will be collected for evaluation of immune-related biomarkers, including complete blood count (CBC), comprehensive metabolic panel (CMP), salivary immunoglobulin A (IgA), and inflammatory cytokines (interleukin-6 [IL-6], tumor necrosis factor alpha [TNF-α], and interleukin-10 [IL-10]). Epigenetic analyses will also be conducted to evaluate changes in gene expression patterns associated with immune function.
Validated subjective outcome measures, including the PROMIS Global Health instrument and the Immune Status Questionnaire, will be administered to assess perceived immune status and overall well-being. Participants will complete compliance and tolerability reporting throughout the study period.
Safety monitoring will include assessment of adverse events, with particular attention to dermatologic, respiratory, and gastrointestinal symptoms potentially associated with essential oil exposure. The study incorporates an adaptive design with planned interim analysis after initial enrollment targets are reached to guide potential expansion or completion of study arms.
The primary objective is to evaluate changes in immune-related biomarkers following 30 days of product use. Secondary objectives include assessment of subjective immune status, hedonic response, and safety/tolerability of aromatic, topical, internal, and combined administration modalities.
- Conditions
- Healthy
- Being tested
- Essential Oil Blend (Botanical Combination Product), Placebo
- Keywords
- Essential oils, Aromatherapy, Immune biomarkers, Topical administration, Oral administration, Cytokines, Inflammation, Epigenetics
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Essential Oil Blend (Botanical Combination Product)Other
A botanical essential oil blend administered via aromatic diffusion, topical application, oral capsule ingestion, or combined use for 30 days. Aromatic administration consists of diffusion of the assigned product overnight (approximately 8 hours) using a standardized protocol. Topical administration consists of application of a diluted preparation to specified skin areas prior to bedtime. Internal administration consists of oral capsule ingestion twice daily with meals. Dosage and administration procedures are standardized across study arms.
PlaceboOther
Matching placebo preparations administered via aromatic diffusion, topical application, oral capsule ingestion, or combined use for 30 days using the same procedures and schedule as the active intervention.
| Study group | Role | What they receive |
|---|---|---|
| Aromatic - Active | Experimental | Participants assigned to this arm will diffuse the investigational essential oil blend overnight (approximately 8 hours) for 30 days according to a standardized protocol. Receives: Other: Essential Oil Blend (Botanical Combination Product) |
| Aromatic - Placebo | Placebo comparator | Participants assigned to this arm will diffuse a placebo preparation overnight (approximately 8 hours) for 30 days using the same protocol as the active aromatic arm. Receives: Other: Placebo |
| Topical - Active | Experimental | Participants assigned to this arm will apply a diluted preparation of the investigational essential oil blend topically prior to bedtime daily for 30 days. Receives: Other: Essential Oil Blend (Botanical Combination Product) |
| Topical - Placebo | Placebo comparator | Participants assigned to this arm will apply a placebo preparation topically prior to bedtime daily for 30 days using the same protocol as the active topical arm. Receives: Other: Placebo |
| Internal - Active | Experimental | Participants assigned to this arm will ingest capsules containing the investigational essential oil blend twice daily with meals for 30 days. Receives: Other: Essential Oil Blend (Botanical Combination Product) |
| Internal - Placebo | Placebo comparator | Participants assigned to this arm will ingest placebo capsules twice daily with meals for 30 days. Receives: Other: Placebo |
| Combined - Active | Experimental | Participants assigned to this arm will use aromatic diffusion, topical application, and oral capsule administration of the investigational essential oil blend daily for 30 days. Receives: Other: Essential Oil Blend (Botanical Combination Product) |
| Combined - Placebo | Placebo comparator | Participants assigned to this arm will use placebo preparations for aromatic diffusion, topical application, and oral capsule administration daily for 30 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Immune Fitness Single-Item Scale (IFIS) Score
Within- and between-group change in perceived immune fitness as measured by the Immune Fitness Single-Item Scale (IFIS), a single-item scale ranging from 0 (very poor) to 10 (excellent), from baseline to Week 4. Weekly IFIS assessments will be used to estimate treatment effects over time. A higher score indicates a perception of greater/stronger immune fitness.
Measured: Baseline to Week 4
Change in Inflammatory Cytokine Levels
Change from baseline to Day 30 in serum concentrations of interleukin-6 (IL-6), tumor necrosis factor alpha (TNF-α), and interleukin-10 (IL-10).
Measured: Baseline and Day 30
Change in Salivary Immunoglobulin A (IgA)
Change from baseline to Day 30 in salivary immunoglobulin A (IgA) concentration.
Measured: Baseline and Day 30
Change in Complete Blood Count (CBC) Parameters
Change from baseline to Day 30 in white blood cell count and differential as measured by complete blood count.
Measured: Baseline and Day 30
Change in Immune-Related Gene Expression Markers
Change from baseline to Day 30 in epigenetic markers associated with immune regulation.
Measured: Baseline and Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start10 Jun 2026
- Primary completion4 Aug 2026
- Study completion17 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a parallel-group design to receive either investigational product or matching placebo administered via aromatic, topical, internal, or combined modalities for 30 days. Participants will remain in their assigned group for the duration of the study. Randomization will be stratified by age group and gender. The study is double-blind, and all intervention groups will be conducted concurrently.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- dōTERRA International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicole Stevens, PhD, Principal investigator, DoTERRA International LLC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07482644
- Sponsor's protocol ID
- DO-126068-OGS
- Acronym
- OGS
- Status last verified
- Oct 2026
- First submitted
- 16 Mar 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of an Essential Oil-Based Product System for Immune Support
- ClinicalTrials.gov ID
- NCT07482644
- Acronym / sponsor ID
- OGS / DO-126068-OGS
- Conditions
- Healthy
- Keywords
- Essential oils, Aromatherapy, Immune biomarkers, Topical administration, Oral administration, Cytokines, Inflammation, Epigenetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- dōTERRA InternationalIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- 4 Aug 2026 (actual)
- Study completion
- 17 Sep 2026 (actual)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, double-blind, placebo-controlled clinical trial will evaluate the safety and efficacy of an essential oil-based product system for immune support in healthy adolescents and adults aged 18-45 years. Participants will be randomized to receive aromatic, topical, internal, or combined use of the investigational product or matching placebo for 30 days.
The aromatic intervention consists of overnight diffusion, the topical intervention consists of diluted application to specified areas prior to bedtime, and the internal intervention consists of oral capsule administration twice daily. Study visits will occur at baseline and at the end of the 30-day intervention period.
Primary outcomes include changes in immune-related biomarkers, including complete blood count, comprehensive metabolic panel, salivary immunoglobulin A (IgA), and inflammatory cytokines (IL-6, TNF-α, IL-10). Epigenetic markers will also be evaluated. Secondary outcomes include validated subjective assessments of immune status and overall well-being, as well as evaluation of safety and tolerability.
The study includes an adaptive design with interim analysis to assess enrollment and study continuation parameters.
Detailed description
This study is a randomized, double-blind, placebo-controlled, parallel-group clinical trial designed to evaluate the safety and efficacy of a multi-modal essential oil-based product system in healthy adolescents and adults aged 18-45 years. Approximately 20 participants per arm will be enrolled and randomized, with the option for sample size expansion following a planned interim analysis.
Participants will be randomized to receive either the investigational product or matching placebo administered through one of four intervention approaches: aromatic use, topical use, internal use, or combined use of all three modalities. The intervention period will be 30 days.
The aromatic intervention consists of diffusion of the assigned product overnight (approximately 8 hours) using a standardized protocol. The topical intervention consists of application of a diluted preparation to specified skin areas prior to bedtime. The internal intervention consists of oral capsule administration twice daily with meals. Participants assigned to the combined group will use all three modalities concurrently. Placebo preparations will be matched for appearance and administration method.
Study assessments will occur at baseline and at the end of the 30-day intervention period. Biological samples will be collected for evaluation of immune-related biomarkers, including complete blood count (CBC), comprehensive metabolic panel (CMP), salivary immunoglobulin A (IgA), and inflammatory cytokines (interleukin-6 [IL-6], tumor necrosis factor alpha [TNF-α], and interleukin-10 [IL-10]). Epigenetic analyses will also be conducted to evaluate changes in gene expression patterns associated with immune function.
Validated subjective outcome measures, including the PROMIS Global Health instrument and the Immune Status Questionnaire, will be administered to assess perceived immune status and overall well-being. Participants will complete compliance and tolerability reporting throughout the study period.
Safety monitoring will include assessment of adverse events, with particular attention to dermatologic, respiratory, and gastrointestinal symptoms potentially associated with essential oil exposure. The study incorporates an adaptive design with planned interim analysis after initial enrollment targets are reached to guide potential expansion or completion of study arms.
The primary objective is to evaluate changes in immune-related biomarkers following 30 days of product use. Secondary objectives include assessment of subjective immune status, hedonic response, and safety/tolerability of aromatic, topical, internal, and combined administration modalities.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
- Model description
- Participants will be randomized in a parallel-group design to receive either investigational product or matching placebo administered via aromatic, topical, internal, or combined modalities for 30 days. Participants will remain in their assigned group for the duration of the study. Randomization will be stratified by age group and gender. The study is double-blind, and all intervention groups will be conducted concurrently.
| Arm | Type | Receives |
|---|---|---|
| Aromatic - Active | Experimental | Other: Essential Oil Blend (Botanical Combination Product)Participants assigned to this arm will diffuse the investigational essential oil blend overnight (approximately 8 hours) for 30 days according to a standardized protocol. |
| Aromatic - Placebo | Placebo comparator | Other: PlaceboParticipants assigned to this arm will diffuse a placebo preparation overnight (approximately 8 hours) for 30 days using the same protocol as the active aromatic arm. |
| Topical - Active | Experimental | Other: Essential Oil Blend (Botanical Combination Product)Participants assigned to this arm will apply a diluted preparation of the investigational essential oil blend topically prior to bedtime daily for 30 days. |
| Topical - Placebo | Placebo comparator | Other: PlaceboParticipants assigned to this arm will apply a placebo preparation topically prior to bedtime daily for 30 days using the same protocol as the active topical arm. |
| Internal - Active | Experimental | Other: Essential Oil Blend (Botanical Combination Product)Participants assigned to this arm will ingest capsules containing the investigational essential oil blend twice daily with meals for 30 days. |
| Internal - Placebo | Placebo comparator | Other: PlaceboParticipants assigned to this arm will ingest placebo capsules twice daily with meals for 30 days. |
| Combined - Active | Experimental | Other: Essential Oil Blend (Botanical Combination Product)Participants assigned to this arm will use aromatic diffusion, topical application, and oral capsule administration of the investigational essential oil blend daily for 30 days. |
| Combined - Placebo | Placebo comparator | Other: PlaceboParticipants assigned to this arm will use placebo preparations for aromatic diffusion, topical application, and oral capsule administration daily for 30 days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy male or female participants aged 18 to 45 years
- Able to read, write, and understand English
- Willing and able to attend study visits at the study site
- Willing to comply with study procedures, including daily use of assigned study product for 30 days
- Willing to refrain from use of essential oils (topical, aromatic, or internal) outside of the study during the study period
Key exclusion criteria (8 listed)
- Known asthma, chronic obstructive pulmonary disease (COPD), chronic lung disease, heart disease, or other medical condition that would make inhalation of essential oils unsafe, as determined by the investigator
- Known allergy or hypersensitivity to essential oils or components of the placebo preparation
- Current use of tobacco products, including smoking, vaping, or chewing tobacco
- Use of recreational drugs
- Pregnant or breastfeeding, or pregnancy within the past 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Essential Oil Blend (Botanical Combination Product)A botanical essential oil blend administered via aromatic diffusion, topical application, oral capsule ingestion, or combined use for 30 days. Aromatic administration consists of diffusion of the assigned product overnight (approximately 8 hours) using a standardized protocol. Topical administration consists of application of a diluted preparation to specified skin areas prior to bedtime. Internal administration consists of oral capsule ingestion twice daily with meals. Dosage and administration procedures are standardized across study arms. | Other | Aromatic - Active, Combined - Active, Internal - Active, Topical - Active |
| PlaceboMatching placebo preparations administered via aromatic diffusion, topical application, oral capsule ingestion, or combined use for 30 days using the same procedures and schedule as the active intervention. | Other | Aromatic - Placebo, Combined - Placebo, Internal - Placebo, Topical - Placebo |
Primary outcome
Change in Immune Fitness Single-Item Scale (IFIS) Score
Time frame: Baseline to Week 4
Within- and between-group change in perceived immune fitness as measured by the Immune Fitness Single-Item Scale (IFIS), a single-item scale ranging from 0 (very poor) to 10 (excellent), from baseline to Week 4. Weekly IFIS assessments will be used to estimate treatment effects over time. A higher score indicates a perception of greater/stronger immune fitness.
Change in Inflammatory Cytokine Levels
Time frame: Baseline and Day 30
Change from baseline to Day 30 in serum concentrations of interleukin-6 (IL-6), tumor necrosis factor alpha (TNF-α), and interleukin-10 (IL-10).
Change in Salivary Immunoglobulin A (IgA)
Time frame: Baseline and Day 30
Change from baseline to Day 30 in salivary immunoglobulin A (IgA) concentration.
Change in Complete Blood Count (CBC) Parameters
Time frame: Baseline and Day 30
Change from baseline to Day 30 in white blood cell count and differential as measured by complete blood count.
Change in Immune-Related Gene Expression Markers
Time frame: Baseline and Day 30
Change from baseline to Day 30 in epigenetic markers associated with immune regulation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Stevens, PhD principal investigator
DoTERRA International LLC.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Essential Oil Blend (Botanical Combination Product) in people with Healthy, run by dōTERRA International at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Immune Fitness Single-Item Scale (IFIS) Score (time frame: Baseline to Week 4). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.